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WuXi Biologics Received First Manufacturing License from Japan and Completed 12 Global Regulatory Inspections in 2021 Year to Date
Sep. 01, 2021
WuXi Biologics Received First Manufacturing License from Japan and Completed 12 Global Regulatory Inspections in 2021 Year to Date
  • Successfully completed over 12 regulatory inspections so far this year

 

Wuxi, China, September 1, 2021 – WuXi Biologics (WuXi Bio) (2269.HK), a global company with leading open-access biologics technology platforms, today announced that it has received the Manufacturing License from Japan’s Minister of Health, Labor and Welfare (MHLW) for its drug substance facility (MFG2) at Wuxi city, China after a 2-day remote GMP inspection. There was no issue during the inspection, demonstrating the company’s strong expertise in addressing global regulatory requirement. WuXi Biologics is conducting the commercial manufacturing of a COVID-19 neutralizing antibody at MFG2 for one of its global partners.

 

This comprehensive inspection was conducted by 3 inspectors and covered the facility’s quality processes and the entire production system. So far, WuXi Biologics has successfully completed nearly 20 regulatory inspections conducted by 7 different agencies including U.S. FDA, EMA, NMPA and 12 inspections since the start of 2021. This successful audit track record demonstrates that the company’s premier quality system is in full compliance with global regulatory requirements.

 

Dr. Chris Chen, CEO of WuXi Biologics said, “Our world-class quality system is the cornerstone to maintain our high sustainable growth and has laid a solid foundation for our global capability expansion to support our customers worldwide. WuXi Biologics will continue to enable global partners to provide life-saving treatments quickly and effectively to benefit patients worldwide.”

 

About WuXi Biologics

 

WuXi Biologics (stock code: 2269.HK), a Hong Kong-listed company, is a leading global open-access biologics technology platform offering end-to-end solutions to empower organizations to discover, develop, and manufacture biologics from concept to commercial manufacturing. The company’s history and achievements demonstrate its commitment to providing a truly ONE-stop service offering and strong value proposition to its global clients.

 

The company is currently conducting on behalf of its clients and partners (as of June 30, 2021) a total of 408 integrated projects, including 212 in pre-clinical development stage, 160 in early-phase (phase I and II) clinical development, 32 in late-phase (phase III) development and 4 in commercial manufacturing. With a total estimated capacity of exceeding 430,000 liters for biopharmaceutical production planned after 2024 in China, Ireland, the U.S., Germany, and Singapore, WuXi Biologics will provide its biomanufacturing partners with a robust and premier-quality global supply chain network.

 

WuXi Biologics views Environmental, Social, and Governance (ESG) responsibilities as an integral component of its ethos and business strategy and aims to become a global ESG leader in biologics manufacturing. We use next-generation clean biomanufacturing technologies and utilize cleaner energy sources. We have also established an ESG committee led by the CEO to increase efficiency while advancing commitment to sustainability. For more information about WuXi Biologics, please visit: www.wuxibiologics.com.

 

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